Mylan Specialty LP, a subsidiary of Mylan Inc. and Pfizer Inc. has signed a license agreement, under which Pfizer will obtain the exclusive rights to market and sell EpiPen injection 0.3/0.15mg in Japan. These products, known in the US as EpiPen (epinephrine) 0.3mg and EpiPen Jr (epinephrine) 0.15mg Auto-Injectors, are for self-administration for the emergency treatment of life-threatening allergic reactions (anaphylaxis) caused by allergens, exercise or unknown triggers.
EpiPen Injection is the only approved epinephrine auto-injector in Japan.
"We are very excited to extend our partnership with Pfizer to this important market," said Mylan chief executive officer Heather Bresch. "Last year, we announced that the Japanese Ministry of Health, Labour and Welfare approved National Health Insurance price listing for EpiPen injection. We have built on this positive momentum by recently launching our next-generation EpiPen injection in Japan. We look forward to achieving success with Pfizer as our partner that furthers our commitment to better serve the people of Japan who suffer from life-threatening allergies."
Under the terms of the agreement, the exclusive rights to market and sell the next-generation EpiPen injection in Japan will be transferred to Pfizer from Mylan Seiyaku. The next-generation EpiPen Injection and EpiPen Auto-Injector are currently available in Japan, the US, Canada, South Africa, Australia and certain European countries.
"Pfizer and Mylan share a deep commitment to serve the people of Japan who are at risk for anaphylaxis," said Ichiro Umeda, president Pfizer Japan. "This agreement will help us to better address this important public health issue in Japan from improving awareness and preparedness, to expanding access to treatment through Pfizer's existing commercial infrastructure and market expertise."
The financial terms of the agreement were not disclosed.
Anaphylaxis is a life-threatening allergic reaction that is rapid in onset and may cause death, either through swelling that shuts off airways or through a significant drop in blood pressure. Anaphylaxis can be triggered by certain foods, insect stings, medications, latex, exercise or other allergens.
A food allergy is a medical condition in which the immune system incorrectly identifies a food protein as a threat and attempts to protect the body against it by releasing chemicals into the blood. The release of these chemicals results in the symptoms of anaphylaxis. According to Japan's "Food Allergy Management Guideline 2008," the foods that most commonly cause anaphylaxis in Japan include hen's eggs, cow's milk products, wheat, shellfish, fruits, buckwheat, fish and peanuts.
EpiPen (epinephrine) 0.3 mg and EpiPen Jr (epinephrine) 0.15 mg Auto-Injectors are approved in the US for the emergency treatment of life-threatening allergic reactions (anaphylaxis) caused by allergens, exercise, or unknown triggers, and for people who are at increased risk for these reactions. EpiPen and EpiPen Jr are intended for immediate self-administration as emergency supportive therapy only. Seek immediate emergency medical treatment after use.
EpiPen Auto-Injectors contain a single dose of epinephrine, which you inject into your outer thigh. Do not inject intravenously. Do not inject into your buttock, as this may not be effective. In case of accidental injection, please seek immediate medical treatment. Epinephrine should be used with caution if you have heart disease or are taking certain medicines that can cause heart-related (cardiac) symptoms.
If you take certain medicines, you may develop serious life-threatening side effects from the epinephrine in EpiPen Auto-Injectors. Be sure to tell your doctor all the medicines you take, especially medicines for asthma. Side effects may be increased in patients with certain medical conditions, or who take certain medicines. These include asthma, allergies, depression, thyroid disease, Parkinson's disease, diabetes, high blood pressure and heart disease.
The most common side effects may include increase in heart rate, stronger or irregular heartbeat, sweating, nausea and vomiting, difficulty breathing, paleness, dizziness, weakness or shakiness, headache, apprehension, nervousness or anxiety. These side effects usually go away quickly, especially if you rest.